An international consortium in which Inserm is participating is launching a large clinical trial in Guinea, Sierra Leone and Liberia. 5,000 adults and children will be recruited.
The fight against Ebola continues in West Africa. While the virus has not been observed since last June, a new clinical trial to assess the effectiveness of different vaccine strategies has been launched in the region under the aegis of the Partnership for Research on Ebola Vaccination (PREVAC). This international consortium brings together Inserm in France, the National Institutes for Health in the United States, the Faculty of Hygiene and Tropical Medicine in London (Great Britain) as well as the health authorities of Guinea and Liberia.
More than 5,000 adults and children living near the epicenter of the epidemic will be recruited from two centers in Guinea (Conakry and Maférinyah) and one in Liberia (Monrovia). A center in Sierra Leone is also expected to participate. “This trial aims to identify the most promising vaccination strategies to protect people from Ebola fever, in order to prevent or quickly control a future epidemic”, explains Inserm in a press release.
3 vaccines evaluated
For this, the PREVAC trial, supported by large pharmaceutical groups, will compare 3 vaccine strategies to a placebo. First in Guinea and Liberia, doctors will administer a combination of 2 vaccines (that of Janssen and Bavarian Nordic) to one group of participants, and the other will receive a placebo. The volunteers will receive a first injection, then a booster 8 weeks later. “Recruitment for this stage started on March 27 in Guinea and April 3, 2017 in Liberia,” says Inserm.
In the second phase, which is expected to start in the second half of 2017, the study will evaluate 2 other vaccine strategies involving the vaccine from Merck Sharp & Dohme, Corp. Participants will receive a first dose of the vaccine, followed 8 weeks later by either a booster with this vaccine or a placebo. A third group will only receive placebo.
Children closely watched
None of these vaccines contain live Ebola virus. The volunteers are therefore not at risk. However, undesirable effects may appear. The participants will therefore be monitored regularly for 12 months to assess the safety and tolerance of the vaccine. Special attention will also be paid to children.
Throughout the trial, an independent oversight committee will review the results seen in 12-17 year olds. While these are reassuring and encouraging, the committee should approve the extension of the trial to children aged 5 to 11. The entry age for the trial could even be lowered to 4 years.
At present, there is no preventive treatment or vaccine against Ebola hemorrhagic fever. In more than two years, 28,646 people have been infected with this virus and 11,323 have died.
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